NDA GROUP EXPANDS SERVICE OFFERINGS AND GEOGRAPHIC REACH APPOINTING NEW US SERVICE AREA LEADERS AND HEAD OF BUSINESS DEVELOPMENT

NDA Group, a world leading drug development consultancy, is expanding its global service offerings and appointing key strategic leaders.

This will allow the company to better support drug product development companies in achieving efficient development and global product approval.

Three new key appointments are announced today to increase the company’s capabilities and reach across the US and EU. Eva Lilienberg joins NDA as the new service area lead for Integrated Development Strategy and Translational Science, Christine Chirdo is NDA’s new Service Area Lead for High stakes meetings, and Barbara Clendenen joins as US Business Development Director.

Through increased focus on development strategies and high-stakes meeting preparation the company will be able to better support development companies with their early to late stage development programs, as well as demonstrate product value through key agency interactions.

“Drug development is growing increasingly complex and companies need strategies that are always keeping the ultimate end in mind – bringing products to patients in need”, said Johan Strömquist, CEO of NDA Group. “As a result, we’ve made critical new appointments to bolster NDA’s translational science and integrated development strategy services, our high-stakes meeting services and business development and client relations.”

Strategy a key focus

NDA is supporting drug developing companies throughout all stages of development and the appointment of Eva Lilienberg as Service Area Lead for NDA’s service areas Translational Science and Integrated Development Strategy will provide clients with a focal point for their strategic needs across the development cycle. Eva Lilienberg will be based out of the company’s head quarter in Stockholm, Sweden.

“Eva Lilienberg has a strong and varied background supporting multiple programs in various therapeutic areas and across the world’s most important markets. Eva’s contributions will help propel client strategy and accelerate programs across the EU and US, as well as result in new intriguing service offerings that enable innovative companies to navigate the regulatory and market access considerations to meet their goals”, said Johan Strömquist.

New High-Stakes Meeting Services

NDA is also expanding into new High-Stakes Meeting services to better support a broad range of critical agency interactions. Through its merger with US Advisory Committee meeting preparation leader, PharmApprove in 2016, NDA strengthened its support for companies approaching health agencies and agency advisory panels for critical communications. The enhanced High-Stakes Meeting services will enable companies to successfully manage and optimise a number of critical agency interactions, such as Advisory Committee Meetings, European Oral Explanations, Scientific Advice, PRAC Public Hearings and HTA and Payer Negotiations.

The new High-Stakes Meeting services will be headed up by Christine Chirdo, based out of Princeton NJ, USA who will be responsible for heading up NDA’s global service area developing the company’s portfolio of high-stakes meeting services.

Laurie Smaldone Alsup, MD, COO/CSO of NDA Group commented: “The unveiling of our enhanced suite of services comes at a point in time where the pressure on drug developing companies to get their message across clearly and succinctly has never been greater. Today regulatory and payer agencies are expanding the opportunities to engage. Failing to prepare for these interactions does not only mean missed opportunities however, but can cause real harm to a company’s aspirations to put a product on the market.”

Expanded support for the US market

To make sure that NDA continues to provide excellent services to clients based across the US and EU as the client base is growing, the company is also announcing the appointment of a new Head of Business Development for the US, Barbara Clendenen. Barbara will be based out of the company’s two offices on the US east coast in Princeton and Boston.

Laurie Smaldone Alsup continued:

“As our business in the US and our client base is growing at an incredible rate it is important for us and for our clients that we have people on the ground who are sensitive to their needs. Barbara Clendenen comes with a wealth of experience that will not just help promote strong relationships with our clients, but that will also help our clients get increased value directly out of every interaction they have with NDA.”

EVA LILIENBERG

Eva comes to NDA after more than 30 years in the industry and brings considerable experience in global product development across US, Europe, Canada and other markets.

She has expertise in multiple therapy areas notably in diabetes, obesity, cardiovascular, respiratory, oncology and inflammation with experience in market access and its importance in clinical development.

She brings broad regulatory and development experience leading international cross functional teams. In her role, as independent consultant Eva has supported many development companies, driving their development programs for US and EU and preparing them for scientific advice.

Before that, Eva served as Executive Director New Products at Merck, Sharp & Dohme (MSD). In addition; Eva has held various senior positions at Merck Europe, Sanofi and AZ as well as supported many companies as a sole contractor.

As the new service area lead for Global Development and Translational Science, Eva will be responsible for strategic development, growth, innovation, procedures and overall quality of all service offerings within the areas of Translational Science and Integrated Development Strategy.

Eva holds a Masters in Pharmaceutical Science, as well as Business & Administration and Behavioural and Social Psychology degrees.

CHRISTINE CHIRDO

Joins NDA from Pfizer and has more than 20 years’ experience as a global and US regulatory professional. In this role, Christine has accrued extensive experience working with FDA, preparing internal teams for major milestone FDA meetings & interacting with other industry associations.

With a background in several therapeutic areas including pain, GI and CNS as well as consumer experience in successful Rx to OTC switches.

As NDA’s new Service Area Lead for High stakes meetings, Christine will be responsible for strategic development, growth, innovation, procedures and overall quality of all service offerings within the area of High-Stakes Meetings.

Christine joins us from Pfizer where she was Director, US Strategy Category Lead. She has significant pharmaceutical experience holding senior positions at Wyeth and GENTA.

Christine holds a B.S. in Biochemistry and a B.S. in Nutritional Science from Rutgers University, NJ.

BARBARA CLENDENEN

A sales management professional with extensive experience in the scientific, life science, healthcare, and clinical services industries, has joined the NDA Group, as Business Development director NDA Regulatory Inc.

Barbara will play a crucial role in creating and maintaining strong client relationships and the development of NDA’s client outreach activities in the US market.

Barbara joins NDA from BIOCLINICA a leading provider of specialty outsourced clinical services for the Pharmaceutical, and Biotech industry, where she was Director of Business Development, eHealth Solutions. Prior to this she was BD Director at Meeting Protocolworldwide and Sales Director at Quorum Review IRB.

Barbara holds a Master’s in Business Administration from Seattle University, coupled with a Bachelor of Science in Microbiology, University of Washington.

About NDA

NDA is an independent consulting group based in Germany, Sweden, Switzerland, United Kingdom and the USA. Its mission is to ensure that good medicines reach patients without unnecessary delay. It accomplishes this by providing the pharmaceutical industry with a comprehensive range of professional services within regulatory affairs, health technology assessment, pharmacovigilance and quality assurance. NDA’s team comprises of more than 25% ex-regulators from major EU Agencies, and a specialist Advisory Board consisting of Europe’s leading regulatory and HTA experts. The NDA Advisory Board provides scientific advice to pharmaceutical companies supporting them in gaining fast and constructive assessment of drug approval applications from European regulatory agencies. www.ndareg.com

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